1
We seek a place beyond imagination
where fertile soil nourishes seeds of change.
We pursue talent and technology
beyond cultural and national boundaries.
We disrupt common paradigms.
And if there are a million people with the same disease,
we’ll find a million individual ways to treat them.
Together with the medical community,
we strive to deliver hope and relief to those who suffer.
Across our planet, home to 7 billion people,
we’re finding new treatments for today,
for tomorrow, for the future of the human race.
And, when the world says there’s no cure,
As long as there are people suffering from disease,
we will continue to innovate...
Addressing unmet medical need
Medical technology has become increasingly sophisticated, but there are still many people suffering from disease around the world. Chugai seeks solutions in areas of unmet medical need – medical need that is not adequately met due to a lack of effective treatments – by confronting the need head on and evolving in all aspects. Based on our business philosophy, “Innovation all for the patients,” we will continue to innovate to bring hope to patients.
...because we are pursuing truly effective treatments.
Promoting personalized healthcare
To address areas of unmet medical need, we don’t just create medicines that are innovative, but pursue treatments that are truly effective. One way we do so is by promoting personalized healthcare – the approach of distinguishing the characteristics of individual patients based on their genetic profile, then designing and implementing an optimal treatment plan for each patient that maximizes efficacy while reducing the risk of adverse reactions. We will continue to lead the industry as a pioneer of personalized healthcare in Japan.
3 3 3
3
Therapeutic Antibodies Therapeutic antibodies are a class of
biopharmaceuticals made using biotechnology. Targeting specific cell types or tissues, they provide a high degree of efficacy with few side effects. These advantages have led to rapid expansion of the market for therapeutic antibodies in recent years. Currently, eight of the ten top-selling drugs in the world are biopharmaceuticals, and five of those are therapeutic antibodies.3 With more than three decades of experience using innovative technologies to create
biopharmaceuticals, Chugai maintains the leading domestic market share for therapeutic antibodies, at 29.7 percent.1
No.
1
1Top share in the Japanesetherapeutic
antibody market
(2016)
1. Copyright © 2017 QuintilesIMS. Source: JPM 2016. Reprinted with permission. The scope of the market is defined by Chugai. 2. Introduced by the U.S. Food and Drug Administration (FDA) in July 2012 to expedite the development and review of medicines to treat
serious or life-threatening diseases or conditions
3. Source: NEW Pharma Future, June 30, 2016, by Ken Pharma Brain
We aim to become a top pharmaceutical company.
Chugai has become the leading provider of biopharmaceuticals and therapeutic antibodies in Japan. That brings us great pride, along with great responsibility. Our alliance with Roche, one of the world’s largest pharmaceutical companies, has helped make the innovative medicines we create available to patients around the world. Today, we are striving to become a top pharmaceutical company that is trusted and supported by our stakeholders. We intend to do much more for the benefit of the medical community and human health worldwide.
S S JPMJPM2201666 RR i t d
S
No.
1
1Top share in the Japanese oncology market
(2016)
ith i i Th f th
ith
115
Countries in which Chugai’sbiopharmaceuticals have been approved
(as of January 2017)
k tti d fi db Ch i
5
Breakthrough therapies2 8.7% 4.5% 5.7% 2016 Product Sales¥472.7
billion(consolidated) 31.0%
50.0%
■Oncology
■Bone and Joint Diseases
■ Renal Diseases
■Transplant, Immunology and Infectious Diseases ■Others
Product Sales by Field
What We Do
Inventing a completely new medicine means exploring a completely new world.
By conducting original research across borders and challenging conventional wisdom,
we have gained world-class research capabilities and unmatched technologies.
We remain committed to creating innovative medicines for patients who are waiting
for new therapies. Continuing innovation that leads to better medical outcomes will
shape the future for patients, for the medical community, and for us.
We can, because we’re Chugai.
To speed up discovery of new antibodies using our proprietary antibody technologies, we have taken steps to strengthen our research activities, including the establishment of Chugai Pharmabody Research (CPR) in Singapore in 2012.
Our research technologies and global
research network are a powerful platform.
We are accelerating discovery of new
therapeutic antibodies by refi ning our strengths
in antibody engineering technologies.
Along with the proprietary research technologies that we pioneered, we take full advantage of the cutting-edge research infrastructure of the Roche Group and a powerful network of outside partners to continuously create new drugs.
Antibody Technology Characteristics
SMART-Ig® Used to create the recycling antibody, which can bind to the target antigen multiple times and therefore prolong the duration of the antibody’s effi cacy
SMART-Fc® Used to create the sweeping antibody, which can eliminate the disease-causing antigen from plasma
ART-Ig® Enables commercial production of the bispecifi c antibody, which is expected to exhibit diverse therapeutic effects by binding to two different types of antigen, unlike conventional antibodies, which only bind to one type of antigen
We are developing proprietary
next-generation antibody technologies.
Our scientists have developed a series of technologies that overcame the limitations of conventional antibody engineering techniques and are leading to the creation of innovative new drugs that target areas of unmet medical need. Contract firms Satellite labs and joint ventures Academic and other research institutes
Chugai
Roche Roche Diagnostics Genentech 7We have also established outstanding
technologies in small molecule drug discovery
and are working on next-generation middle
molecule drug discovery.
Many patients are waiting anxiously for a breakthrough drug. We want to
fulfill their wishes by making much-needed medicines available as
quickly as possible. Utilizing our network with Roche, we develop drug
candidates into medicines and spread their value globally. We also
continue to deliver high-quality medicines from our production
operations, which are among the most advanced in Japan.
Top-level quality and speed
Chugai’s production infrastructure, including biopharmaceutical API production facilities, ranks among the top in Japan in both quality and capacity. We also have a flexible development and production system that allows for a rapid shift to commercial-scale manufacturing of new products.
Strong production functions for
biopharmaceuticals underpin our ability to
deliver innovative drugs.
With numerous in-house projects and our alliance partner Roche, we have one of the richest
development pipelines in Japan.
We are the domestic industry leader in participation in multinational studies, which enable simultaneous global filings for regulatory approval. This supports our goal of bringing innovative drugs to patients as quickly as possible.
Stage Oncology (As of February 1, 2017)
Phase III
AF802 Non-small cell lung cancer
(NSCLC) [1st line] (Overseas)
RG435 Renal cell carcinoma
RG1273 Breast cancer (adjuvant)
Gastric cancer
RG3502 Breast cancer (adjuvant)
RG7159 Indolent non-Hodgkin’s lymphoma (NHL)
RG7446
NSCLC, NSCLC (adjuvant), Small cell lung cancer, Urothelial carcinoma, Muscle invasive bladder cancer (adjuvant), Renal cell carcinoma,
Renal cell carcinoma (adjuvant), Breast cancer
Phase II Malignant pleural mesotheliomaRG435
Phase I GC33 Hepatocellular carcinoma* CKI27 Solid tumors (Domestic/ Overseas) RG7596 NHL RG7604 Solid tumors RG7440 Solid tumors ERY974 Solid tumors (Overseas) RG6078 Solid tumors
Bone and Joint Diseases/Autoimmune Diseases
Phase III Osteoporosis (China)ED-71 Systemic sclerosisMRA Neuromyelitis opticaSA237
*
Renal Diseases
Phase I HyperphosphatemiaEOS789
Central Nervous System/Others
Phase III Alzheimer’s diseaseRG1450 Hemophilia AACE910
Phase II Idiopathic pulmonary fi brosisRG3637
CIM331 Pruritus in dialysis patients,
Atopic dermatitis*
URC102 Gout (Overseas)
Phase I Alzheimer’s diseaseRG7412 Spinal muscular atrophyRG7916
PCO371 Hypoparathyroidism (Overseas) SKY59 Paroxysmal nocturnal hemoglobinuria
In-house project ◆Project based on PHC
*
Multinational study managed by Chugai Pharmaceutical ★Development out-licensed to Galderma (Overseas)/Maruho (Japan)Note: Each project is identifi ed by development code and indication.
9
We want patients to have access to better treatments and more treatment options.
To make that possible, we must continuously generate valuable information. And to
that end, we must further refine the expertise that allows us to propose various
treatments to healthcare professionals as part of our efforts to advance medical care.
Contributing to the advancement
of healthcare
Healthcare has become more advanced and complex, and the healthcare environment is changing. In response, we strive to support the multidisciplinary team approach to care, in which teams of doctors, pharmacists, nurses and other professionals are formed to provide coordinated patient-oriented treatment. We also provide solutions adapted to variations in regional characteristics. Our medical representatives* (MRs) focus on consultation,
using their specialized knowledge to propose and provide information to healthcare professionals on the optimal treatment options and side-effect management strategies for each patient. They also help to promote appropriate use of drugs to ensure that patients can use medicines with confidence.
We support the increasingly important
multidisciplinary team approach and
community care.
Our aim is healthcare that is personalized.
* Medical representatives are employees responsible for providing information on medicines.
As part of our efforts to ensure the safety of our
pharmaceuticals, we are upgrading our information provision function using ICT tools, in addition to strengthening our communication and enhancing epidemiology functions.
We have a world-class safety management
system, but are always trying to make it better.
We are taking steps to provide the most
useful safety data.
With expert safety assessment and sharing of adverse drug reaction information with Roche, Chugai provides fast and timely reporting and disclosure in line with global standards.
Patient Groups Industry Groups Academia
Chugai Regulatory
Agencies
Media
Patients Related Groups
Physicians Pharmacists
What We Do
Together with Stakeholders
Support for Para-Sports
Chugai co-sponsors the Japanese Para-Sports Association as an official partner to support top athletes competing around the world. In addition, Chugai actively backs para-sports in other ways to help realize the para-sports philosophy of “creating a vital and inclusive society.”
Enhancing Community
Welfare
Each year for more than 30 years, Chugai has donated specially equipped welfare vehicles to help people with physical disabilities carry on their lives in a familiar environment. The total number of vehicles donated through this program was 243 as of December 31, 2016. Vehicles have been donated to recipients in all of Japan’s 47 prefectures.
Educating the Next
Generation
Chugai hosts various biology lab classes for elementary, junior high school and high school students to show children the fun of science. It has also established courses at universities to raise interest in health and medical treatment.
13
Environmental Protection
Activities
Caring for the global environment is one of Chugai’s Core Values. Based on that value, we make efforts to minimize our environmental footprint in accordance with environmental laws and regulations. Our aim is to protect the global environment, which is part of the Chugai Business Conduct Guidelines.
Relay For Life
Chugai participates in and co-sponsors a variety of activities to support cancer patients and their families. One such activity is Relay For Life Japan, an awareness support campaign that forges ties in the fight against cancer. Chugai employees took part in this event at 29 locations throughout Japan in 2016.
Monitoring solar power generation at the Ukima site
For the third consecutive year, Chugai was selected as a “Nadeshiko Brand” company in recognition of its exceptional efforts to promote the success of women in the workplace.
Diversity Management
Chugai is emphasizing diversity management to enable a rich variety of employees to work enthusiastically and create new value. We have introduced a program for nurturing female leaders, and conduct various forums and training programs as part of our efforts to improve workplace environments.
Diversity guidebook
Chugai’s Mission Statement
Mission
Chugai’s mission is to dedicate itself to adding exceptional value through the creation of innovative medical products and services for the benefit of the medical community and human health around the world.
Core Values
1. The primary focus of all our activities is patients and consumers.
2. In all our activities we are committed to the highest ethical and moral standards.
3. We value employees who develop profound expertise and broad perspectives and pursue innovation and challenges without fear of failure.
4. Wherever we operate around the world we seek to understand and respect people and cultures and to behave as good corporate citizens.
5. We promote an open and active corporate culture that respects individuality, ability and teamwork. 6. We care about the global environment.
7. We aim to achieve a fair return for our shareholders and to disclose information appropriately and in a timely manner.
Envisioned Future
As a most important member of the Roche Group, we aim to become a top Japanese pharmaceutical company by providing a continuous flow of innovative new medicines domestically and internationally.
Innovation All for the Patients
Business Plan IBI 18
15
Chugai’s Seven Unique Strengths
High product potential that addresses unmet
medical need1
One of the richest pipelines2 in Japan
Support for healthcare delivery Commitment to safety
management
Knowledge and experience as a pioneer
in personalized healthcare (PHC)4 Strategic alliance3 with
the Roche Group
Cutting-edge drug discovery technologies, especially biotechnology
Chugai’s innovative products and advanced technologies are all developed with patients in mind. Based on internal and external interviews, we identified Chugai’s seven core strengths.
1. Medical need that is not adequately met due to a lack of effective treatments 2. Drug development projects from the initial stage of development to market launch
3. Based on the strategic alliance with Roche concluded in December 2001, Chugai and Nippon Roche K.K., a wholly owned subsidiary of Roche, merged in October 2002.
4. A treatment method in which treatment plans are devised and executed according to the molecular and genetic information of individual patients
The Process of Identifying Our Seven Strengths
In our project to become a top pharmaceutical company, which started in 2009, we visualized the intangible strengths that Chugai has built, and shared 96 examples of those strengths within the company.
In a project to develop our public relations strategy, which started in 2013, we conducted internal and external interviews based on the 96 examples. We then evaluated those strengths from the standpoints of value to patients and competitive advantage, resulting in 25 categories.
We organized these 25 categories and distilled them down to seven strengths as a basic message to be used in communicating with stakeholders.
Visualization Distillation Down to Seven Strengths Analysis of Value
Network
(As of April 1, 2017)⑤◆3
◆2 ❷ ❶② ⑦ Osaka-Kita Branch Osaka-Minami Branch Nara and Wakayama Branch Hyogo Branch
Hiroshima Branch Yamaguchi Branch Tottori and Shimane Branch Okayama Branch
Kagawa and Tokushima Branch Ehime and Kouchi Branch Fukuoka and Oita Branch Nagasaki and Saga Branch Kumamoto Branch
Kagoshima and Miyazaki Branch Okinawa Branch
□ Regional Management Offices
(RMO)
Hokkaido and Tohoku RMO Kanto-Kita and Koshinetsu RMO Kanto-Minami RMO
Tokai and Hokuriku RMO Kansai RMO
Chugoku and Shikoku RMO Kyushu RMO
① Chugai Clinical Research Center Co., Ltd. ② Chugai Research Institute for Medical Science, Inc. ③ Chugai Business Support Co., Ltd.
④ Medical Culture Inc. ⑤ Chugai Distribution Co., Ltd.
⑥ Chugai Pharma Manufacturing Co., Ltd. ⑦ Forerunner Pharma Research Co., Ltd.
Chugai Pharmaceutical Domestic Subsidiaries
■ Chugai Pharma U.K. Ltd. (London, U.K.)
▲■ Chugai Pharma Europe Ltd. (London, U.K.)
▲■Chugai sanofi-aventis S.N.C. (Gentilly Cedex, France)
■Chugai Pharma Europe Ltd. Germany Branch (Frankfurt, Germany)
■Chugai Pharma France SAS (Paris, France)
● C&C Research Laboratories (Gyeonggi, Korea)
▲Chugai Pharma Science (Beijing) Co., Ltd. (Beijing, China)
■Chugai Pharma China Co., Ltd. Beijing Branch
(Beijing, China)
■Chugai Pharma China Co., Ltd. Guangzhou Branch
(Guangzhou, China)
●Chugai Pharmabody Research Pte. Ltd. (Singapore, Republic of Singapore)
■Chugai Pharma China Co., Ltd. Shanghai Branch
(Shanghai, China)
▲■Chugai Pharma Taiwan Ltd. (Taipei, Taiwan)
■Chugai Pharma China Co., Ltd. (Jiangsu, China)
▲Chugai Pharma USA, Inc. (New Jersey, U.S.A.)
●▲◆■Chugai Pharmaceutical Co., Ltd.
Chugai’s Global Network
●Research ▲Development ◆Production ■□Marketing
★❸◆1 ①③④⑥
★Head Office
1-1 Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo 103-8324 Japan Tel +81-(0)3-3281-6611
URL: https://www.chugai-pharm.co.jp/ english
● Research Laboratories
❶Fuji Gotemba Research Laboratories ❷Kamakura Research Laboratories ❸Ukima Research Laboratories
◆ Plants
(Chugai Pharma Manufacturing Co., Ltd.) ◆1 Ukima Plant
◆2 Fujieda Plant ◆3 Utsunomiya Plant
■ Branches
Hokkaido Branch
Miyagi and Yamagata Branch Kita-Tohoku Branch
(Iwate/Aomori/Akita) Fukushima Branch Saitama Branch Ibaraki Branch
Gunma and Tochigi Branch Niigata Branch
Nagano and Yamanashi Branch Tokyo Branch 1
Tokyo Branch 2 Tokyo Branch 3 Tokyo Tama Branch Chiba Branch Yokohama Branch Atsugi Branch Aichi Branch Gifu and Mie Branch Shizuoka Branch Kyoto and Shiga Branch
17 Company name Chugai Pharmaceutical Co., Ltd.
Representative Osamu Nagayama, Chairman and CEO
Foundation March 10, 1925
Establishment March 8, 1943
Stated capital ¥72,967 million
2016 core basis results*
Revenues ¥491.8 billion
Operating profit ¥80.6 billion
Net income ¥56.8 billion
* IFRS results excluding gains and losses associated with non-recurring events
Fiscal year-end December 31
Number of
employees 7,245 (consolidated)
Principal lines Manufacturing, sales and import/ of business export of pharmaceuticals
Head office Nihonbashi Mitsui Tower (front desk: 15th floor)
1-1 Nihonbashi-Muromachi 2-chome,
Chuo-ku, Tokyo
Representative Director,
Chairman & CEO Osamu Nagayama
Representative Director &
Deputy Chairman Motoo Ueno
Representative Director,
President & COO Tatsuro Kosaka
Director,
Executive Vice President & CFO Yoshio Itaya
Outside Director (Independent*) Yasuo Ikeda
Outside Director (Independent*) Masayuki Oku
Outside Director (Independent*) Yoichiro Ichimaru
Director Christoph Franz
Director Daniel O’Day
Director Sophie Kornowski-Bonnet
Audit & Supervisory
Board Member (Full-time) Shunji Yokoyama
Audit & Supervisory
Board Member (Full-time) Mamoru Togashi
Audit & Supervisory
Board Member (Outside) Hisashi Hara
Audit & Supervisory Board
Member (Outside) (Independent*) Takaaki Nimura
*Independent officer pursuant to the regulations of Tokyo Stock Exchange, Inc.
Corporate Data
(As of December 31, 2016)Directors & Officers
(As of April 1, 2017)About Roche
Established in 1896, Roche is a pharmaceutical
company headquartered in Basel, Switzerland.
It employs approximately 94,000 people in over
100 countries, and generated net sales of 50.6
billion Swiss francs in 2016. Roche contributes
to medicine in a wide range of fields through
its two business segments, pharmaceuticals
and diagnostics. Central to the Roche Group’s
strategy is personalized healthcare, in which
biomarkers and diagnostic tests are used to
identify the patients most likely to respond to
a particular drug.
Roche signed an alliance with Chugai in 2001, and
is now the majority shareholder in Chugai.
U.S.-based Genentech, one of the world’s leading
biotechnology companies, is also a member of the
Roche Group.
Corporate Data
Website
https://www.chugai-pharm.co.jp/english/
Social Media
Twitter URL https://twitter.com/chugai_cc ID @chugai_cc
